Effect of Adding TENS to Mediterranean Diet on Appetite and Liver Enzymes in Nonalcoholic Fatty Liver Patients

NCT07200934 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005933
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to identify the effect of adding TENS to the Mediterranean diet on appetite and liver enzymes in Nonalcoholic fatty liver patients.

Conditions

Nonalcoholic Fatty Liver

Outcome Measures

Primary Outcomes (3)

• Visual analogue scale for appetite (VAS)

  This method is used to evaluate the appetite level of fatty liver patients before and after treatment procedures. This method usually consists of a set of questions assessing hunger, fullness/satisfaction, desire to eat and prospective food intake the question is presented with a 100 mm horizontal line scale.

  12 weeks

• Levels of liver transaminases aspartate transaminase (AST)

  It will be measured pre and post-treatment for all participants in both groups.

  12 weeks

• Levels of liver alanine transaminase (ALT)

  It will be measured pre and post-treatment for all participants in both groups.

  12 weeks

Secondary Outcomes (3)

• Body mass index (BMI)

  12 weeks

• Relative fat mass (RFM)

  12 weeks

• Fatigue Severity Scale (FSS)

  12 weeks

Study Arms (2)

TENS + Mediterranean Diet

EXPERIMENTAL

This group will consist of 25 patients, who will receive TENS treatment at T6 dermatome for 30 minutes, 3 times per week for 12 weeks, in addition to following Mediterranean diet for 12 weeks.

Device: Transcutaneous electrical stimulation (TENS); Other: Mediterranean Diet

Mediterranean Diet

ACTIVE COMPARATOR

This group will consist of 25 patients, who will follow Mediterranean diet only for 12 weeks.

Other: Mediterranean Diet

Interventions

Transcutaneous electrical stimulation (TENS) DEVICE

The negative/active pad surface electrode will be applied at the T6 dermatome on the abdomen (is located at the left upper quadrant of the abdomen, 2 cm below the ribcage at the left midclavicular line) for stimulation and the passive/positive electrode will be applied on the left T6 costovertebral junction to complete the circuit. * The specific parameters of TENS will be burst mode, 2.0 Hz frequency, and 300 micro-seconds width * The patients will receive 3 times 30 min session each week for a period of consecutive 12 weeks. * The intensity of TENS will be gradually increased from 0 mA till the subject felt a comfortable tingling sensation beneath the electrode without any muscle contraction and pain.

TENS + Mediterranean Diet

Mediterranean Diet OTHER

The recommended composition of Mediterranean diet regimen: is characterized by a high intake of plant foods, fruits, vegetables, breads and other cereals (traditionally minimally refined), potatoes, beans, nuts and seeds; minimally processed, fresh fruits as a typical dessert, with sweets containing sugars or honey a few times per week; .a high intake of olive oil (especially virgin and extra-virgin olive oil) as the main source of fat; a moderate intake of dairy products (mostly as cheese and yoghurt); zero to four eggs per week; low to moderate amounts of fish and poultry; low amounts of red meat. The diet plan included generally 50% carbohydrates (from vegetables, fruits, legumes, and whole grains), 35% fats (from healthy oils, nuts, seeds, and fish), and 15% protein (from legumes, fish, nuts, dairy, poultry, and eggs).

Mediterranean Diet; TENS + Mediterranean Diet

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The age will range from 35-45 years old.
• BMI (Body Mass Index 30-34.9 kg/m2.)
• With fatty liver infiltration confirmed by abdominal ultrasound
• Elevated of liver enzymes as a primary marker
• All patients are psychologically stable.

You may not qualify if:

• History of cardiovascular or respiratory disease.
• If any known endocrine diseases e.g. Hypothyroidism (which elevates liver enzymes and effects on appetite)
• Any acute or chronic illness causing elevated liver enzymes other than fatty liver e.g. Hepatitis b, Hepatitis c
• Any neurological illness or impairment can effect on sensation
• Patients associated with infections, mental or malignant conditions.
• Patients who have undergone any gastric surgery e.g. Bariatric surgery
• Taking dietary supplement for weight reduction.
• Patients who participating in any other exercise program.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Internal Medicine Hospital Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Transcutaneous Electric Nerve Stimulation; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Nesreen Ghareeb El-Nahas, PhD

  Professor, Cairo university

  STUDY CHAIR

• Salma Ibrahim AL Ghitany, PhD

  Lecturer, Cairo university

  STUDY DIRECTOR

• Shawky Abdelhamid Fouad Abdel Gawad

  Professor, Cairo university

  STUDY DIRECTOR

Central Study Contacts

Doaa Anwar Mohamed Ali, B.Sc

CONTACT

+20 100 310 8951; dr.doaanwar@hotmail.com

Salma Ibrahim AL Ghitany, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: September 30, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 14, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

EG (1)